A Study of Familial and Genetic Aspects of Adult T-Cell: Leukemia/Lymphoma , Tropical Spastic Paraparesis, and Infective Dermatitis

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00340821
First received: June 19, 2006
Last updated: March 2, 2011
Last verified: March 2011
  Purpose

Doctors of the University of West Indies, the Caribbean Epidemiology Center (CAREC) and the National Cancer Institute have been studying the epidemiology of HTLV-I and its role in the etiology and pathogenesis of adult T-cell leukemia/lymphoma (ALT), and aggressive T-cell lymphoma. The purpose of the current study is to evaluate familial and genetic aspects of ATL and its relationship to two other HTLV-I related conditions, HTLV-I associated myelopathy also known as tropical spastic paraparesis (HAM/TSP), and infective dermatitis. Enrollment of infective dermatitis cases was recently added and the disease entity is thought to be a harbinger for later development of either ATL or HAM/TSP. The purpose of this study is to interview patients with these conditions and perform laboratory studies (specifically, HLA and other viral or genetic studies) to better understand these diseases and their relationship to the HTLV-1 virus and the family history and genetic factors that may be involved as well.


Condition
HTLV-I

Study Type: Observational
Official Title: A Study of Familial and Genetic Aspects of Adult T-Cell Leukemia/Lymphoma, Tropical Spastic Paraparesis and Infective Dermatitis in Jamaica

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1800
Study Start Date: May 1993
Estimated Study Completion Date: March 2011
Detailed Description:

Doctors of the University of West Indies, the Caribbean Epidemiology Center (CAREC) and the National Cancer Institute have been studying the epidemiology of HTLV-I and its role in the etiology and pathogenesis of adult T-cell leukemia/lymphoma (ALT), and aggressive T-cell lymphoma. The purpose of the current study is to evaluate familial and genetic aspects of ATL and its relationship to two other HTLV-I related conditions, HTLV-I associated myelopathy also known as tropical spastic paraparesis (HAM/TSP), and infective dermatitis. Enrollment of infective dermatitis cases was recently added and the disease entity is thought to be a harbinger for later development of either ATL or HAM/TSP. The purpose of this study is to interview patients with these conditions and perform laboratory studies (specifically, HLA and other viral or genetic studies) to better understand these diseases and their relationship to the HTLV-1 virus and the family history and genetic factors that may be involved as well.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

All cases of ATL and TSP which satisfy the case definitions above. Cases will be selected regardless of HTLV-1 sero-status.

EXCLUSION CRITERIA:

Cases who have none of the first three priority family members available i.e. parents, offspring and siblings, will be excluded from this study however summary data will be maintained.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00340821

Locations
Jamaica
University of the West Indies
Kingston, Jamaica
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00340821     History of Changes
Other Study ID Numbers: 999996018, OH96-C-N018
Study First Received: June 19, 2006
Last Updated: March 2, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
HTLV-I

Additional relevant MeSH terms:
Dermatitis
Leukemia-Lymphoma, Adult T-Cell
Paraparesis
Paraparesis, Spastic
Paraparesis, Tropical Spastic
Skin Diseases, Infectious
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Deltaretrovirus Infections
HTLV-I Infections
Immune System Diseases
Immunoproliferative Disorders
Infection
Leukemia
Leukemia, Lymphoid
Leukemia, T-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Myelitis
Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Neurologic Manifestations
Paresis
Retroviridae Infections
RNA Virus Infections
Signs and Symptoms
Skin Diseases
Spinal Cord Diseases

ClinicalTrials.gov processed this record on October 23, 2014